Marketing Authorisation Division (Human)

Division/Coordination/Unit

Marketing Authorisation Division (Human)

General e-mail address

General phone number

+ 32 2 528 40 00

Key tasks

• The following up of MA applications for medicinal products for human use
• Receipt and validation of MA applications
• Evaluation and management, in the broadest sense, of the application files for a MA or for a registration of homoeopathic and herbal medicines and processing of applications for amendments to existing MA and registrations
• Receipt and administrative monitoring of ASMFs
• Coordination and follow-up of applications in function of the deadlines
• Ensuring the link between the pharmaceutical industry, national and international competent authorities such as EMA, internal and external assessors and partner institutions such as the WIV-ISP
• Ensuring the secretariat of the CGH-CMH, HCG-HCM and CKG-CMP
• Active participation in consultations with other competent authorities, such as CMDh or with BRAS regarding regulatory affairs
• Drafting of PARs
• Administrative closing of files and delivery of Mas
• Issuing STA